Ignite Creation Date:
2025-12-24 @ 9:45 PM
Ignite Modification Date:
2026-01-01 @ 12:20 PM
Study NCT ID:
NCT02275832
Status:
COMPLETED
Last Update Posted:
2015-04-22
First Post:
2014-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of 3% Minoxidil Lotion for Beard Enhancement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-21', 'studyFirstSubmitDate': '2014-10-23', 'studyFirstSubmitQcDate': '2014-10-24', 'lastUpdatePostDateStruct': {'date': '2015-04-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'The change of hair diameter after 16 weeks from baseline', 'timeFrame': 'baseline and 16 weeks'}, {'measure': 'Number of participants with adverse events', 'timeFrame': 'baseline and 16 weeks'}, {'measure': 'Patient satisfaction by self-assessment questionnaires', 'timeFrame': 'baseline and 16 weeks'}], 'primaryOutcomes': [{'measure': 'The change of global photographic assessment after 16 weeks from baseline', 'timeFrame': 'baseline and 16 weeks'}], 'secondaryOutcomes': [{'measure': 'The change in number of hairs after 16 weeks from baseline', 'timeFrame': 'baseline and 16 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Beard Enhancement']}, 'referencesModule': {'references': [{'pmid': '24471459', 'type': 'RESULT', 'citation': 'Lee S, Tanglertsampan C, Tanchotikul M, Worapunpong N. Minoxidil 2% lotion for eyebrow enhancement: a randomized, double-blind, placebo-controlled, spilt-face comparative study. J Dermatol. 2014 Feb;41(2):149-52. doi: 10.1111/1346-8138.12275. Epub 2013 Nov 8.'}, {'pmid': '22594928', 'type': 'RESULT', 'citation': 'Suwanchatchai W, Tanglertsampan C, Pengsalae N, Makornwattana M. Efficacy and safety of bimatoprost 0.03% versus minoxidil 3% in enhancement of eyebrows: a randomized, double-blind, split-face comparative study. J Dermatol. 2012 Oct;39(10):865-6. doi: 10.1111/j.1346-8138.2012.01579.x. Epub 2012 May 17. No abstract available.'}, {'pmid': '23193746', 'type': 'RESULT', 'citation': 'Tanglertsampan C. Efficacy and safety of 3% minoxidil versus combined 3% minoxidil / 0.1% finasteride in male pattern hair loss: a randomized, double-blind, comparative study. J Med Assoc Thai. 2012 Oct;95(10):1312-6.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine efficacy and safety of 3% minoxidil lotion for beard enhancement.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male\n\nExclusion Criteria:\n\n* serious underlying diseases.\n* history of beard/ hair treatment before 6 months\n* history of surgery or trauma on beard area.\n* history of minoxidil allergy'}, 'identificationModule': {'nctId': 'NCT02275832', 'briefTitle': 'Efficacy and Safety of 3% Minoxidil Lotion for Beard Enhancement', 'organization': {'class': 'OTHER', 'fullName': 'Mae Fah Luang University Hospital'}, 'officialTitle': 'Efficacy and Safety of 3% Minoxidil Lotion for Beard Enhancement : A Randomized, Double-blind, Placebo-controlled Study', 'orgStudyIdInfo': {'id': 'REH-57077'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Minoxidil', 'description': '3% Minoxidil lotion is applied twice daily to the beard.', 'interventionNames': ['Drug: 3 % Minoxidil lotion']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo is applied twice daily to beard.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': '3 % Minoxidil lotion', 'type': 'DRUG', 'armGroupLabels': ['Minoxidil']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bangkok', 'country': 'Thailand', 'facility': 'MFL University Hospital (Bangkok)', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'overallOfficials': [{'name': 'Chuchai Tanglertsampan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MFL University Hospital (Bangkok)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mae Fah Luang University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assitant Professor', 'investigatorFullName': 'Chuchai TANGLERTSAMPAN, MD', 'investigatorAffiliation': 'Mae Fah Luang University Hospital'}}}}